Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

April 17, 2024 updated by: Chandler S Cortina, Medical College of Wisconsin

A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals

There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California San Francisco (UCSF)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus (CU Anschutz)
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center (MCC)
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University (Boston U)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Rochester, New York, United States, 14623
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • University of Cincinnati (UC)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington (UW)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Eligible patients are those who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from the sex they were assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

Description

Inclusion Criteria:

  1. Age 18 years of age or older
  2. Breast cancer diagnosis (including DCIS)
  3. Persons who identify as gender and/or sex that is different from the sex they were assigned at birth

Exclusion Criteria:

  1. Age <18 at time of breast cancer diagnosis
  2. Cis-gendered persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transgender and Gender-Diverse Persons with Breast Cancer
Patients who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS)), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from their sex assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer Diagnosis Method
Time Frame: 33 years
Describe the method of breast cancer diagnosis (self detected vs screen detected vs healthcare provider detected) and compare to the published data from cisgender women by determining means and standard deviation and comparing rates using the Wilcoxon signed-rank test.
33 years
Breast Cancer Risk Factors
Time Frame: 33 years
Assess breast cancer risk factors (family history, genetics, etc.), including a prior use of gender-affirming hormone therapy and/or gender-affirming surgery on tumor receptor status and stage at diagnosis using t-test and chi-squared test.
33 years
Breast Cancer Management Strategies
Time Frame: 33 years
Report breast cancer management strategies (type of breast surgery, receipt of radiation, etc.) through descriptive and comparative staststics with a focus on the use of adjuvant endocrine therapy and gender-affirming hormone therapy for patients with hormone-receptor positive disease using t-test and chi-squared test.
33 years
Outcomes Data
Time Frame: 33 years
Breast cancer local and distant recurrence, overall survival, and disease-free survival using Kaplan-Meier analysis. Cox Proportional Hazards model will be used to estimate the effect of various factors on distant metastasis-free and overall survival.
33 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Chandler S Cortina, The Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00043417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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